PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.

  • 40,910 total recalls
  • #1 of 12 among categories
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.

40,910
total recalls
#1 of 12
category rank by events
9%
graded high-severity
FDA Devices
top issuing agency

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

40,910 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · NHTSA federal recall filings · 2026-08-29

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Recalls in Medical Devices

Newest first · Page 624 of 819

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-0050-D20) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibri…

Cardiac Science Corporation

FDA Devices Moderate Mar 2, 2016

Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-0050-620) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548700 (XMD P/N 70-0050-518) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

Fresenius Medical Care Renal Therapies Group, LLC

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548600 (XMD P/N 70-0050-B16) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemente…

Zimmer Biomet, Inc.

FDA Devices Critical Mar 2, 2016

Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter…

Cook Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549480 (XMD P/N 70-0050-424) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-l…

Teleflex Medical

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548960 (XMD P/N 70-0050-F20) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasi…

Hill-Rom, Inc.

FDA Devices Critical Mar 2, 2016

Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated ca…

Cook Inc.

FDA Devices Moderate Mar 2, 2016

LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This de…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548810 (XMD P/N 70-0050-G18) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548440 (XMD P/N 70-0050-B14) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548450 (XMD P/N 70-0050-C14) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549310 (XMD P/N 70-0050-122) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548480 (XMD P/N 70-0050-F14) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549600 (XMD P/N 70-0050-G24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549580 (XMD P/N 70-0050-E24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549520 (XMD P/N 70-0050-824) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548800 (XMD P/N 70-0050-F18) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, poly…

Zimmer Biomet, Inc.

FDA Devices Low Mar 2, 2016

BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: …

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549330 (XMD P/N 70-0050-322) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Synthes Small Electric Drive (SED)

The Anspach Effort, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548900 (XMD P/N 70-0050-920) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicat…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548510 (XMD P/N 70-0050-216) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

What to do with this

Monitoring medical devices? Start here.

  • Check a specific product against the full federal archive before you use or buy it. Recall checker
  • Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
  • Sort the whole archive by severity to see the highest-risk active recalls first. Rankings

Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.

Nearby categories

Adjacent product categories that share hazard patterns or regulatory oversight.

Data sources

Category data as of Jul 29, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 29, 2026.